FDA Adverse Event Malfunction Summary report: N

VITALITY

MDR report key: 1850263 · Received October 1, 2010

Report

Report Number: 2124215-2010-16684
Event Type: Malfunction
Date Received: October 1, 2010
Date of Event: July 6, 2010
Report Date: July 6, 2010
Manufacturer: GUIDANT CRM CLONMEL IRELAND
Product Code: LWS
Removal / Correction Number: Z-0047-2008 TO Z-0053-20
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: PA
Reporter Occupation: MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

Additional Manufacturer Narrative · 1

A REVIEW OF DEVICE MEMORY REVEALED THAT THE DEVICE DECLARED END OF LIFE (EOL) AFTER EXPERIENCING ONE CHARGE TIME GREATER THAN 30 SECONDS. ALTHOUGH THE BATTERY ITSELF HAD NOT DEPLETED PREMATURELY, EOL WAS TRIGGERED EARLIER THAN EXPECTED BY EXTENDED CHARGE TIMES DUE TO A HIGHER-THAN-TYPICAL BUILD-UP OF INTERNAL BATTERY IMPEDANCE. THIS ISSUE IS DISCUSSED IN THE Q3 2010 PRODUCT PERFORMANCE REPORT.

Description of Event or Problem · 1

BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), WHICH IS PART OF THE MID-LIFE DISPLAY OF REPLACEMENT INDICATORS PRODUCT UPDATE CLASSIFIED AS A PRODUCT ADVISORY AND INITIALLY COMMUNICATED ON 3/10/2007, REACHED ELECTIVE REPLACEMENT INDICATOR (ERI) WITH MONITORING VOLTAGE MEASUREMENT OF 2.719 VOLTS AND A CHARGE TIME MEASUREMENT OF 22.219 SECONDS. END OF LIFE (EOL) WAS EXHIBITED WITH A MONITORING VOLTAGE OF 2.69 VOLTS AND A CHARGE TIME MEASUREMENT OF 31.564 SECONDS. THERE WAS A CONCERN THAT THE BATTERY DEPLETED EARLIER THAN EXPECTED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS ASSOCIATED WITH THIS CLINICAL OBSERVATION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	VITALITY	IMPLANTABLE CARDIOVERTER DEFIBRILLATOR	LWS	GUIDANT CRM CLONMEL IRELAND	T127

Patients

Seq	Age	Sex	Outcome	Treatment
1	60 YR			T127\| 6947\| 1388T